Terazol (Terconazole)

TERAZOL® Janssen-Ortho Terconazole Antifungal

Action and Clinical

The exact pharmacologic mode of action of terconazole is uncertain; however, it may exert its antifungal activity by disruption of normal fungal cell membrane permeability. Terconazole exhibits fungicidal activity in vitro against the genus Candida. Both the yeast and mycelial forms of C. albicans are sensitive to terconazole.

Following intravaginal administration of terconazole in humans, absorption ranged from 5 to 8% in 3 hysterectomized patients and 12 to 16% in 2 nonhysterectomized subjects with tubal ligations. After single and multiple doses of terconazole 0.4% (20 mg) vaginal cream, the mean peak plasma concentration for both treatments was 0.004 g, indicating no accumulation of terconazole following repeated intravaginal dosing.

Indications And Clinical Uses:

For the local treatment of vulvovaginal candidiasis (moniliasis). The diagnosis of monilial infection should be confirmed by microscopic examination of a KOH smear and/or by culture.

The ovules and cream may be used in pregnant patients during the second and third trimesters if the physician considers it essential to the welfare of the patient (see Precautions, Pregnancy). The therapeutic effect of terconazole is not affected by oral contraceptive usage, menstruation or previous monilial infection.

Contra-Indications:

Patients known to be hypersensitive to terconazole or to any components of the ovule or cream.

Warnings in Clinical States: None.

Precautions:

General: Terconazole cream and ovules should be discontinued and patients should not be retreated if sensitization, vulvovaginal irritation, fever, chills or flu-like symptoms are reported during use.

Photosensitivity reactions were observed in some normal volunteers following repeated dermal application of terconazole 2.0% and 0.8% creams under conditions of filtered artificial ultraviolet light. Photosensitivity reactions have not been observed in clinical trials in patients who were treated vaginally with terconazole 0.4%, 0.8% or 1.6% vaginal cream.

The base contained in the ovule formulation may interact with certain natural rubber products, such as those used in vaginal contraceptive diaphragms or condoms. Concurrent use is not recommended. The cream may be considered for use under these conditions.

If there is a lack of response to terconazole therapy, appropriate microbiological studies (standard KOH smear and/or cultures) should be repeated to confirm the diagnosis and rule out other pathogens.

Intractable candidiasis may be the presenting symptom of unrecognized diabetes mellitus. In these cases, appropriate diagnostic tests for diabetes should be done.

Children: Safety and efficacy in children have not been established.

Pregnancy: Terconazole should not be used in the first trimester of pregnancy.

In studies, over 600 pregnant patients have used terconazole during the second and third trimesters with no apparent adverse effect on the course of pregnancy. These studies have not shown increased risk of abnormalities when administered during this period.

Pregnant patients should be advised to exercise caution in the use of the vaginal applicator.

Lactation: It is not known whether terconazole is excreted in human milk. Should the decision be made to use this drug, nursing should be discontinued during therapy.

Adverse Reactions:

:During controlled clinical studies conducted in the U.S., 284 patients with vulvovaginal candidiasis were treated with terconazole 80 mg vaginal ovules, 521 patients were treated with terconazole 0.4% vaginal cream and 297 patients were treated with terconazole 0.8% vaginal cream.

Terazol 3 Vaginal Ovules (terconazole 80 mg): Based on comparative analyses with placebo and a standard agent, the adverse experiences considered adverse reactions most likely related to terconazole 80 mg vaginal ovules.

The adverse drug experience on terconazole 80 mg ovules most frequently causing discontinuation was burning (2.5% vs 1.4% with placebo) and pruritus (1.8% vs 1.4% with placebo). The terconazole therapy-related dropout rate was 3.5% and the placebo therapy-related dropout rate was 2.7%.

Terazol 7 Vaginal Cream (terconazole 0.4%): Based on comparative analyses with placebo and a standard agent, the adverse experiences considered to be most likely related to terconazole 0.4% vaginal cream.

Vulvovaginal burning (5.2%), itching (2.3%) or irritation (3.1%) occurred less frequently with terconazole 0.4% vaginal cream than with the vehicle placebo. The adverse drug experience most frequently causing discontinuation of treatment with terconazole cream was vulvovaginal itching (0.6%) which was lower than the incidence for placebo (0.9%). The terconazole therapy and the placebo therapy-related dropout rate was 1.9%.

Terazol 3 Vaginal Cream (terconazole 0.8%): Based on comparative analyses with placebo and a standard agent, the only adverse experiences considered adverse reactions to terconazole 0.8% vaginal cream.

Fever (1.0% vs. 0.3% with placebo) has been reported. The therapy-related dropout rate was 2.0%. The adverse drug experience on terconazole 0.8% most frequently causing discontinuation was vulvovaginal itching (0.7%), which was similar to the incidence for placebo (0.3%).

Symptoms And Treatment Of Overdose:

Overdose of terconazole in humans has not been reported to date.

Dosage And Administration:

Terazol 3 Vaginal Ovules: 1 ovule is administered intravaginally once daily at bedtime for 3 consecutive days.

Terazol 7 Vaginal Cream: One applicatorful (5 g) of vaginal cream (20 mg terconazole) is administered intravaginally once daily at bedtime for 7 consecutive days. In addition, a thin layer of vaginal cream is applied for 7 consecutive days directly to the vulva and (0.8% terconazole) massaged in gently.

Terazol 3 Vaginal Cream: One applicatorful (5 g) of vaginal cream (40 mg terconazole) is administered intravaginally once daily at bedtime for 3 consecutive days. In addition, a thin layer of vaginal cream (0.8% terconazole) is applied for 3 consecutive days directly to the vulva and massaged in gently.

Terazol 3 Dual-Pak Package: One vaginal ovule is administered intravaginally once daily at bedtime for 3 consecutive days. In addition, a thin layer of vaginal cream is applied for 3 consecutive days directly to the vulva and massaged in gently.

Before prescribing another course of therapy of terconazole, the diagnosis of monilial infection should be confirmed by microscopic examination of a KOH smear and/or by culture. Intractable candidiasis may be the presenting symptom of unrecognized diabetes mellitus. In these cases appropriate diagnostic tests for diabetes should be done. The therapeutic effect of terconazole products is not affected by oral contraceptive usage or menstruation.

Availability And Storage:

Terazol 3 Vaginal Ovules: Each elliptically-shaped, white to off-white, 2.5 g ovule contains: terconazole 80 mg. Nonmedicinal ingredients: butylated hydroxyanisol, cetyl alcohol, hydrogenated vegetable oils, isopropyl myristate, polysorbate 60, polysorbate 80, purified water and stearyl alcohol. Packages of 3 with an Ortho vaginal applicator.

Terazol 7 Vaginal Cream: Each g of white to off-white, water washable cream contains: terconazole 0.4%. Nonmedicinal ingredients: butylated hydroxyanisol, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, purified water and stearyl alcohol. Tubes of 45 g with an Ortho vaginal applicator.

Terazol 3 Vaginal Cream: Each g of white to off-white, water washable cream contains: terconazole 0.8%. Nonmedicinal ingredients: butylated hydroxyanisol, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, purified water and stearyl alcohol. Tubes of 20 g with an Ortho vaginal applicator.

Terazol 3 Dual-Pack Package: 3 Terazol 3 vaginal ovules, an Ortho vaginal applicator and a 9 g tube of Terazol 3 vaginal cream.

Store at controlled room temperature (15 to 30°C).

TERAZOL® Janssen-Ortho Terconazole Antifungal

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